Overview

This trial is active, not recruiting.

Conditions obesity, appetite
Treatments functional magnetic resonance imaging, dual energy x-ray absorptiometry, questionnaires, mood and appetite ratings, test meals, computer tests, intravenous catheter (iv) placement
Sponsor University of Washington
Collaborator Fred Hutchinson Cancer Research Center
Start date August 2010
End date August 2016
Trial size 108 participants
Trial identifier NCT02483663, 38970-D

Summary

Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model family-based
Time perspective prospective
Arm
functional magnetic resonance imaging fMRI
Measure brain activity.
dual energy x-ray absorptiometry DXA
Body composition measurements.
questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
mood and appetite ratings
Answer questions about how you are feeling at the moment.
test meals
Breakfast, a snack, and lunch provided during study visit.
computer tests
Perform a series of computer tests to determine reaction time.
intravenous catheter (iv) placement
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.
functional magnetic resonance imaging fMRI
Measure brain activity.
dual energy x-ray absorptiometry DXA
Body composition measurements.
questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
mood and appetite ratings
Answer questions about how you are feeling at the moment.
test meals
Breakfast, a snack, and lunch provided during study visit.
computer tests
Perform a series of computer tests to determine reaction time.
intravenous catheter (iv) placement
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.

Primary Outcomes

Measure
Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose)
time frame: Baseline
Brain activation during fMRI in satiety-related regions
time frame: Baseline
Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA)
time frame: Baseline
DNA evaluation of FTO genotypes
time frame: Baseline
Objective satiety: caloric and macronutrient intake
time frame: Baseline
Subjective satiety: visual analog scale (VAS) scores and appeal ratings
time frame: Baseline

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - Ability and willingness to come with their twin to the University of Washington (Seattle) - Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or - Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2 - Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2 Exclusion Criteria: - History of weight loss surgery or active participation in weight loss program - Major medical problem (e.g., diabetes, cancer) - Current use of weight loss medications or other medications known to alter appetite - Pregnancy or menopause - MRI contraindication (i.e., implanted metal, claustrophobia) - Lifetime eating disorder - Current smoking - Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males) - Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures. - BMI < 18.5 or > 45 kg/m^2 - Allergies to study foods or inability to taste - Twins were raised apart - Co-twin not eligible or not willing to participate

Additional Information

Official title Brain Regulation of Appetite in Twins
Principal investigator Ellen Schur, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Washington.